Virological Impact of Switching from Efavirenz and Nevirapine-based First-Line ART Regimens to Dolutegravir

Mylan Laboratories Limited0 个研究点目标入组 1,254 人开始时间: 2019年4月4日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Participants will eligible for study participation if they meet the following criteria:
•1.HIV-1 infection, as documented by confirmed licensed rapid test kit at any time prior to study entry
•2.Taking TDF/XTC/EFV or NVP based ART
•3.Male or female, age 18 or over
•4.Ability and willingness to provide informed consent and willingness to comply with the requirements of the protocol, including being observed for 144 weeks on study, and complete all scheduled appointments and lab draws according to the national treatment guidelines and study protocol

•Participants will be excluded from participation if they meet any of the following criteria
•1.HIV-2 infection
•2.Signs or symptoms consistent with established cirrhosis
•3.Pregnant or lactating or those who are actively trying to conceive, or who are not using a consistent and reliable method of birth control
•4.Severe chronic diarrhoea lasting for more than 30 consecutive days at time of screening
•5.Active Tuberculosis and on Rifampicin based anti-tuberculous therapy
•6.History of any chronic or acute illness or other condition that in the opinion of the investigator would interfere with the conduct or completion of the study
•7.Receiving a prohibited medication for treatment of another medical condition
•8.Current enrolled in an experimental protocol, or is receiving an experimental medication or vaccine
•9.Current alcohol abuse or illicit drug use that in the opinion of the investigator may interfere with the patient’s ability to comply with the protocol requirements
•10.History or current diagnosis of a psychiatric illness or major depression
•11.Exhibition non-adherence to prior medical care and treatments
•12. ALT > 2.5 times the upper limit of normal at baseline
•13.Creatinine clearance <50 ml/min at study enrolment
•14.Compulsory detention (i.e. involuntary incarceration) at the time of screening and enrolment

发起方